Food Safety Modernization Act (FSMA)

Time to Re-register Your Food Facilities With FDA

For those who import food products, it is time to re-register your food facilities with FDA. Starting in 2012, companies were required to re-register their food facilities with FDA on a biennial basis. The re-registration period is from October 1 through December 31 of each even-numbered year.

Re-registration can be down via the FDA Food Facility Registration website. Please note that “renewing” your registration is different from “updating” your registration. If you recently “updated” your registration, you still need to go into the FDA Food Facility Registration website to “renew” your registration.

Remember that the FDA Food Facility re-registration requirement applies to both food importers as well as their overseas manufacturers. Please remind your food manufacturers to renew their FDA Food Facility registration before the end of the year. As your food manufacturers go through the renewal process, please also be aware of the U.S. Agent appointment process. Domestic food facilities are not required to appoint a U.S. Agent. However foreign food facilities are required to appoint a U.S. agent. It is extremely important for U.S. Agents to remember that under the FDA Food Safety Modernization Act (FSMA), the U.S. agent is responsible for paying for any FDA re-inspections of foreign food facilities. FDA’s fees are not cheap. FDA will be billing for foreign travel at a rate of $305 per hour. Therefore I would HIGHLY recommend that U.S. food facilities think twice before accepting responsibility to be the U.S. Agent for foreign food manufacturers.

Food facilities have until the end of this year to get re-registered. Please do not waste time and get your re-registration completed early to avoid being denied import privileges by FDA.

Let me know if you have any questions.

-Jimmy Ting

GWL Corp

Great World Customs Service

jimmyting@gwlcorp.com

tel# 650-873-9050 x1019

MUST READ for Food Importers: FDA Publishes Proposed Rule for Foreign Supplier Verification Programs for Importers of Food

This is posting is a MUST READ for importers of food products (whether for humans or animals).

1.) The FDA published on July 26, 2013 a set of proposed regulations meant to help ensure that imported food meets the same level of public health protection as that required of domestic food producers. In doing so, they have created a proposed program (Food Safety Verification Program) that I believe will put a great burden on the food importing community.

The FSVP required importers to conduct audits and keep records of their suppliers. There are various exceptions.  However most medium and large importers of food products will be required to greatly increase the record keeping of their food imports. The FDA has published a number of diagrams/flow charts that help explain to importers the possible required tasks they will have to follow. I highly recommend that importers familiarize themselves with the rules. 

The potential impact of the rules is quite vast. I expect larger importers with strong relationships with large food manufacturers probably will be able to implement the FSVP the most smoothly. While they will have the most work to do, they will also have the manpower, expertise, and relationships necessary to make sure the FSVP is implemented. I am most worried for mid-sized and especially smaller food importers.

 

2.) FDA also published a proposed rule for Accreditation of Third-Party Auditors. What importers should understand is how FDA proposes to use 3rd party auditors. Thus far, they have mentioned three possible uses:

  • FDA is expected to create a Voluntary Qualified Importer Program (VQIP) which is expected to allow for expedited review and entry of food into the United States. Such a program may be welcome news to importers who are tired of the length of time it is taking FDA to currently process entries. Under FDA’s proposed regulation, importers would have to import from certified facilities (reviewed by the accredited third-party auditors).
  • FDA will have the power to required manufactures be certified by accredited third-party auditors as a condition of entry if FDA deems the product is a safety risk.
  • FDA also expects that importers may voluntarily begin to rely on third-party auditors as a progress of complying the the FSVP even in instances where it is not a requirement to use a third-party auditor.

Keep in mind that the rules mentioned above are only “proposed” regulations. Now is the time for importers to put in their comments.

– Jimmy Ting

jimmyting@great-world.com

t: 650-873-9050 x1019

 

 

Stricter Enforcement of FDA Food Facility Registration Requirements under the FSMA

We’ve noticed that one byproduct of the new biennial Food Facility Registration requirement is stricter enforcement of registration rules when filing Prior Notice (PN). We have seen FDA cracking down on PN filings. In particular, FDA seems to be taking a close look at actual foreign Food Facility Registration number to make sure that the party

a.) is the actual manufacturer of the product or the facility that actually repacked the product.

b.) has authority to register the Food Facility with FDA.

We have seen two cases already where FDA questioned the authenticity and validity of the Food Facility Registration number of the foreign food facility. In both cases, FDA eventually refused the goods. The products had to be either exported or destroyed.

Keep in mind that the refusal of the product occurs at the time of filing of the PN. This is different from a typical FDA hold that occurs at the time of Customs entry submission. With a hold during the filing of PN, Customs cannot release the goods either. The goods end up sitting at the port accumulating storage charges while the issue is resolved. Most importers are used to being able to receive and hold their shipments while waiting for FDA to release goods. This is not the case with an FDA hold at the PN level.

My recommendation to the importing community is if the shipper is NOT the actual manufacturer OR the repacker of the food product, you MUST get the Food Facility Registration number and information of the actual manufacturer or repacker. FDA has on occasion accepted the name and address of the manufacturer / repacker without the Food Facility Registration number ONLY if the that manufacturer / repacker has already registered with FDA using that same name and address. Unfortunately, there is no system of verifying this with FDA without actually submitting the entry to FDA. This ends up being a great risk. You don’t know if the name address is listed with FDA until you submit the entry. I don’t believe this is a risk that most importers will find worth taking. Therefore it behooves the importer to get the actual FDA Food Facility Registration number of the foreign manufacturer / repacker.

Let me know if you have any questions or comments.

-Jimmy Ting

jimmyting@great-world.com

FDA Biennial Food Facility Registration now AVAILABLE!

All food facilities (foreign and domestic) who have previously registered their facilities with FDA must now re-register. Under the Food Safety & Modernization Act of 2011, food facilities are now required to re-register every two years (from October 1 through December 31 of each even-numbered year). Previously registered facilities can now begin re-registering via FDA’s Food Facility Registration website. Please make sure to click the link for “Biennial Registration.”

Failure to register may result in the suspension of FDA Food Facility Registration which may ultimately lead to the FDA holds on imported goods. Domestic importers should inform their overseas suppliers to re-register ASAP.

One word of caution to importers who are asked by their overseas suppliers to act as a U.S. Agent. Don’t do it, unless you are ready to face the consequences. I know in the past that many importers have been willing to help foreign facilities by acting as their U.S. agent. Under the FSMA, the U.S. Agent is liable for FDA foreign re-inspection fees. The posted/suggested rate of of inspection for foreign facilities is currently set at $289/hour. I doubt most importers would be willing to accept this type of liability.

Let me know if you have any questions.

Jimmy Ting

jimmyting@great-world.com

 

 

Changes to Food Facility Registration under FSMA

Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed by President Obama on January 4, 2011. I have listed out the major changes below:

1.)    Frequency – every two years. In the past, food facilities only need register once. Under the FSMA, food facilities must re-register every two years.

2.)    Start date: The official start date was October 1, 2012. However FDA has delayed the start of re-registration until further notice (http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm?source=govdelivery). Importers should continue to watch out for when the start date opens up.

3.)    Requirement of food facilities to indicate secondary products produced (in addition to the primary product produced).

4.)    “Voluntary” additional information – FDA will be sending out a separate form after the registration is complete. This separate form will ask for “voluntary” information that will be used to determine if the facility is “high risk.” It would seem obvious that it would be in the facility’s best interests to complete the form. However importers should be very careful when completing this form. It will ask for specific information about potential hazards the preventive control measures that the facility is taking.

5.) Re-Inspection Fee: FDA will have the right to inspect food facilities. The part that importers should be aware of is that FDA will be authorized to charge a “re-inspection” fee if a re-inspection is required. For domestic food facilities, the cost of the re-inspection will be born by the domestic facility. However for foreign facilities, the U.S. agent listed on the Food Facility Registration will be responsible for the costs related to the re-inspection.

More information about Registration can be found at the following FDA website: http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm

Registration should be be made via the following FDA website: http://www.access.fda.gov/

There is no fee for FDA Food Facility Registration.

Feel free to contact me with questions.

-Jimmy Ting

jimmyting@great-world.com